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Clinical Trials/NCT01057043
NCT01057043CompletedNot Applicable

Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.

Charite University, Berlin, Germany2 sites in 1 country40 target enrollmentStarted: January 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control.

Detailed Description

Cupping is a traditional therapy in many cultures of the world and is used to treat osteoarthritis of the knee. In this randomised trial we want to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control. Pulsatile cupping is administered by a special cupping machine (HeVaTec) with silicone cupping glasses to the knee joint. Pulsatile pressure is generated by a pump that generates vacuum.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Osteoarthritis of the knee according ACR-criteria
  • •X-ray classification minimum Kellgren-Lawrence criteria grade 2
  • •Pain Intensity > 40 mm VAS
  • •Only therapy with NSAIDin the last 4 weeks
  • •Informed consent

Exclusion Criteria

  • •Use of anticoagulants (Phenprocoumon, Heparin)
  • •Coagulopathy
  • •Cupping in the last 12 months
  • •Intraarticular injection of corticosteroids or NSAID into the knee joint in the last 4 months
  • •Use of systemic corticosteroids in the last 4 weeks
  • •Physical therapy, leeches or acupuncture in the last 4 months
  • •Other CAM therapies for the osteoarthritis in the last 4 weeks
  • •Arthroscopy of the knee joint in the last 12 months
  • •Paracetamol allergy or intolerance

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score

Time Frame: 4 weeks

Secondary Outcomes

  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores(12 weeks)
  • Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)(week 4 and 12)
  • Quality of Life (SF 36)(4 and 12 weeks)
  • Adverse events and serious adverse events(continously)
  • Global assessment of efficacy by patients(week 4 and 12)
  • Use of rescue medication (paracetamol)(weeks 1-4)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Benno Brinkhaus

Prof. MD

Charite University, Berlin, Germany

Study Sites (2)

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